| CTRI Number |
CTRI/2025/02/080587 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Catheter Related Blood Stream Infections (CRBSI) |
|
Scientific Title of Study
|
Catheter related blood stream infections(CRBSI): Incidence, risk factors and antimicrobial susceptibility in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SWATI |
| Designation |
PG 1ST YEAR RESIDENT |
| Affiliation |
School of Medical Sciences and Research, Sharda Hospital |
| Address |
Department of Anesthesiology, School of Medical Sciences and Research, Sharda Hospital
,
Plot no 32, 34, Knowledge Park 3,
Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9759356614 |
| Fax |
|
| Email |
swatiy0102@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr RAM MURTI SHARMA |
| Designation |
Professor |
| Affiliation |
School of Medical Sciences and Research, Sharda Hospital |
| Address |
Department of Anesthesiology,
School of Medical Sciences and Research, Sharda Hospital,
Plot no 32, 34, Knowledge Park 3,
Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
7798881243 |
| Fax |
|
| Email |
sharmarammurti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SWATI |
| Designation |
pg 1st year resident anaesthesia |
| Affiliation |
School of Medical Sciences and Research, Sharda Hospital |
| Address |
Department of Anesthesiology, School of Medical Sciences and Research, Sharda Hospital
,
Plot no 32, 34, Knowledge Park 3,
Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
09759356614 |
| Fax |
|
| Email |
swatiy0102@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Medical Sciences and Research, Sharda Hospital
,
Plot no 32, 34, Knowledge Park 3,
Greater Noida, Uttar Pradesh, 201310 |
|
|
Primary Sponsor
|
| Name |
School of medical sciences and research |
| Address |
Plot No 32, 34, Knowledge Park 3, Greater Noida, 201310, INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SWATI |
Sharda Hospital, School of medical sciences and research |
Department of
Anesthesiology, 2nd
floor, B block Gautam
Buddha Nagar, UTTAR
PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar UTTAR PRADESH |
9759356614
swatiy0102@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years of age and, admitted in ICU with CVC catheter and HD catheter in situ for more than 48 hrs.
|
|
| ExclusionCriteria |
| Details |
1.Patients admitted from other hospital with CVC catheter/HD catheter.
2.Immunocompromised or those with terminal or severe illness (advanced or metastatic cancer, advanced congestive heart failure, stroke, coma).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CRBSI is suggested when blood from the CVC demonstrates microbial growth at least 2 h earlier than growth is detected in blood collected simultaneously from a peripheral vein. |
first at baseline then after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To identify possible risk factors associated with CRBSI.
2.To isolate microbial agents causing CRBSI.
3. To study antimicrobial sensitivity patterns.
|
when CRBSI is suspected |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [SWATIY0102@GMAIL.COM].
- For how long will this data be available start date provided 10-10-2024 and end date provided 10-10-2060?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Catheter-related bloodstream infection (CRBSI) is defined as the presence of bacteremia originating from central venous catheter. It is one of the most frequent, lethal, and costly complications of central venous catheterization and also the most common cause of nosocomial bacteremia. Intravascular catheters are integral to the modern practices and are inserted in critically-ill patients for the administration of fluids, blood products, medication, nutritional solutions, and for hemodynamic monitoring. Central venous catheters (CVCs) pose a greater risk of device-related infections than any other types of medical device and are major causes of morbidity and mortality. The definitive diagnosis of catheter infection can be made by using a combination of clinical signs and symptoms together with the various culture techniques. Patients with CVC catheters developing fever or chills, unexplained hypotension, and no other localizing sign suggest possibility of CRBSI. Catheter site infection is indicated by the presence of erythema, swelling, tenderness, and purulent drainage around the catheter exit and the part of the tunnel external to the cuff. Risk factors for CRBSI include immunocompromised status, neutropenia Burns, Malnutrition, BMI >40, Prolonged hospitalization before catheter insertion, emergency catheter insertion, incomplete adherence to aseptic technique, multiple manipulations of the catheter, failure to remove unnecessary catheter. The administration of parenteral nutrition through intravascular catheters increases CRBSI risk. Local risk factors, such as poor personal hygiene, occlusive transparent dressing, moisture around the exit site, S. aureus nasal colonization, and contiguous infections support the role of bacterial colonization in the pathogenesis of CRBSI. The antimicrobial susceptibility patterns will help clinician to decide correct choice of antibiotics and antimicrobial stewardship. Antibiotic therapy for catheter-related infection is often initiated empirically. The initial choice of antibiotics depends on the severity of the patient’s clinical disease, the risk factors for infection, and the likely pathogens associated with the specific intravascular device. There are no compelling data to support specific recommendations for the duration of therapy for device-related infection. Antibiotic therapy for CRBSI is used in conjunction with systemic antibiotic therapy and involves installing a high concentration of an antibiotic, to which the causative microbe is susceptible in the catheter lumen. The likelihood of success varies with the site of infection |